Gina Chen Email and Phone Number

1. License renewal for all drug products and medical devices2. Life cycle management of drug products and medical devices (kinds of variations, PMF renewal and QSD registration etc.)3. Assist cross-functional affairs: PSUR and RMP submission4. Assist APAC cross-functional meeting held in Taiwan for RA and QA

Assist general regulatory affairs, collect and prepare documents for internal inspection.

1. Prepare documents and follow compliance to meet TFDA requirements or requests. Related Affairs were listed as below.(1) Based on TFDA feedback letter to prepare for AtO.(2) Types of variation on PI, carton, labeling.2. Administrative affairs_Archive regulatory announcement.3. Assist ppts integration for primary regulatory training course.

1. Support the customer related complaint and internal discrepancy cases initiated reporting the correct information and sample shipping to Global Complaint Team for investigation.2. Assist product release related affairs3.Execute general administrative affairs

1. Execute the project for Chinese pharmacopoeia related content harmonisation focused on API monograph addition and revision cooperated with TFDA.2. Assist generic pharmaceutical industrial improvemental affairs on local regulation and international cooperation.3. Hold the internation conference and training courese with differenet topics focused on pharmaceutical regulation and patent linkage.

1. Execute the project from government on natural product research and development, its final target would be IND submission to TFDA and complete it belonging pre-clinical research.2. Execute analytic method development and method validation, instrumental validaiton (like HPLC).3. Execute analytic methods of quality control on natural products with HPLC, TLC, LC-MS/MS, microscope indentification...etc)4. Write related projects proposals and final report.